First traditional-use registration for St John’s Wort and Valerian combination

The pharmaceutical service provider Diapharm has succeeded in obtaining traditional-use registration for a combination product containing St John’s Wort and Valerian extracts for the treatment of mental exhaustion (fatigue) and related sleep disturbance.

Until now, the time-consuming marketing authorisation process was the only path to being able to market products containing St John’s Wort and Valerian. Diapharm has been able to register with the German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) a combination product consisting of both active pharmaceutical ingredients (APIs) with an appealing indication and a consumer-friendly dosage. The combination product is available for licensing.

“The combination of traditionally used herbal APIs is a valuable opportunity for advancement in this market segment,” said Dr Rainer Kolkmann, Head of Product Development at Diapharm. “By registering interesting combination products, we are paving the way to making traditional herbal active pharmaceutical ingredients interesting for the market again.”

Just a few weeks ago, Diapharm and one of its clients obtained decentralised procedure (DCP) registration in seven EU countries for the combination of St John’s wort and black cohosh for relieving the symptoms associated with menopause. The company has helped manage over 500 medicinal product registrations and marketing authorisation processes for phytopharmaceuticals throughout Europe.